ML20198J418

Forwards Memo to Commission W/Encls,Including Final Rulemaking Plan, Exempt Distribution & Use of Radioactive Drug Containing One Uci of C-14 Urea (Parts 30 & 32), for Review

ML20198J418
Person / Time
Issue date:	01/30/1997
From:	Morrison D NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:	Thompson H NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
Shared Package
ML20013E023	List: ML20198H571 ML20198H672 ML20198H718 ML20198H780 ML20198H830 ML20198H875 ML20198H887 ML20198H907 ML20198J119 ML20198J157 ML20198J188 ML20198J224 ML20198J252 ML20198J270 ML20198J298 ML20198J324 ML20198J404 ML20198J418 ML20198J664 ML20198J741 ML20198J766 ML20198J793 ML20198J830 ML20198J869 ML20198J932 ML20198J978 ML20198J988 ML20198J995 ML20198K019 ML20198K055 ML20198K065 ML20198K118 ML20198K151 ML20198K202 ML20198K217
References
FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-051, AF70-1-51, NUDOCS 9801140128
Download: ML20198J418 (52)

Text

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!*' E NUCLEAR R EGULATORY COMMISSION g '/ WASHINotoN, o.C. 70$$M001 f January 30, 1997 MEMORANDUM TO: Hugh L. Thompson, Jr.

Acting Executive Director for Operations FROM: D1vid L. Morrison, Director '

Office of Nuclear Regulatory Research ,/l - wd# '

SUBJECT:

FINAL RULEMAKING PLAN: EXEMPT DISTRIBUTION AND USE OF A RADIOACTIVE DRUG CONTAINING ONE MICROCURIE OF CARBON 14 UREA (PARTS 30 AND 32)

The attached memorandum to the Commission with its enclosures, including the final rulemaking plan, are provided for your review and transmittal to the Commission. This rulemaking plan was developed in response to a petition for rulemaking submitted by Tri Med Specialties, Inc. i in accordance with the SRM COMSECY 96 035 dated June 11,1996, a copy of the draft rulemaking plan, recommending a generallicense approach, was provided to the Agreement States for review and comment. The comment period closed on October 31,1996. Ten comment letters were received from the Agreement States. Six States agreed with the staff's initial position to grant the petition by making the "C urea capsules available to any physician under a geneiallicense. However, three States -

Georgia, Illinois, and New York - while agreeing that the petition ,

should be granted, opposed the stalf's recommendation and argued that  ;

the capsules should be made available as exempt material. One State.

Oregon, stated that it would continue to require that any person who administers a radioactive drug be specifically licensed, in addition, there were some comments related to the process of Agreement State involvement in NRC rulemaking that the stati believes were addressed in SECY 96-035, and, theref ore, are not addressed in the memorandum to the Commission or in the final rulemaking plan.

Af ter considering Agreement States' comments, the staff has changed its recommendation. We now recommend that manufacturers and distributors be permitted to distribt to this radioactive drug as exempt material to "any person" who is permitted to receive and use the drug under the appropriate Federal or State law gove.ning the distribut.on and use of the drug.

ll you have any questions, please contact Sam Jones (415 6198).

Attachment:

Memo to the Commission w/ enclosures 9901140129 990109

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• January 30, 1997 MEMORANDUM TO: Hugh L. Thompson, Jr.

Acting Ex:cutive D!r:ctor for Operations FROM: David L. Morrison, Director /s/ David L. Marrison Office of Nuclear Regulatory Research

SUBJECT:

FINAL RULEMAKING PLAN: EXEMPT DI: TRIBUTION AND USE OF A RADIOACTIVE C'oUG CONTAINING ONE MICROCURIE OF CARBON 14 UREA (PARTS 30 AND 32)

'ihu attached memorandum to the Commission with its onclosures, including the final rulemaking plan, are provided for your review and transmittal to the Commission. This rulemaking plan was developed in response to a petition for rulemaking submitted by Tri-Mod Specialtios, Inc.

In accordance with the SRM COMSECY 96 035 dated June 11,1996, a copy of the draft rulemaking plan, recommending a generallicense approach, was provided to the Agreement States for review and comment. The comment period closed on October 31,1996. Ton comment letters were received from the Agreement States. Six States agreed with the staff's initial position to grant the petition by making the "C-urea capsules available to any physician under a generallicenso. However, throo States -

Georgia, Illinois, and New York - while agrooing that the petition should be granted, opposed the staff's recommendation and argued that the capsules should be made available as exempt material. One Stato, Oregon, stated that it would continue to require that any person who administors a radioactive drug bo specifically licensed.

In addition, there were somo comments related to the process of Agreement State involvement in NRC rulemaking that the staff believes were addressed in SECY 96-035, and, therefore, are not addressed in the memorandum to the Commission or in the final rulemaking plan.

Af ter considering Agreement States' comments, the staf f has changed its recommc wtation. We now recommend that manufacturers and distributors be permitted to distribute this radioactivo drug as exempt material to "any person" who is permitted to receive and use the drug under the appropriate Federal or State law governing the distribution and use of the drug.

If you have any questions, please contact Sam Jones (415 6198).

Attachment:

Memo to the Commission w/ enclosures DOCUMENT NAME: o:\tso\c14momo See next page for Distribution To roccivo a copy of this docurncnt, indicate in the box "C" = copy without attachment / enclosure ' B' = copy with 9ttachment/onclosure, "N* = No copy

• See previous concurrences OFFICE DRA/RPHEB DRA/RPHEB D/DRA/RES DIRES

d NAME: SJones': nb CTrottier

• BMorris

• DMorrison DATE: 11/15/96 11/18/96 1/27/97 1/g /97 A OFFICIAL RECORD COPY RES FILE CODE pO.: 3A-3

IQ: The Commissioners FROM: Hugh L. Thompson, Jr.

Acting Executive Director for Operations

SUBJECT:

FINAL RULEMAKING PLAN: EXEMPT DISTRIBUTION AND USE OF RADIOACTIVE DRUG CONTAINING ONE MICROCURIE OF CARBON 14 UREA (PARTS 30 AND 32)

PURPOM:

To inform the Commission of the staff's rulemaking plan for amending Parts 30 and 32 to allow the distribution of a radioactive drug containing one microcurie of "C-urea as an exempt material for "in vivo" diagnostic testing.

S.ARGROUND:

On October 6,1994, the Commission docketed a petition f or rulemaking (Docket No.

In a letter dated August 23,1994, PRM 3512) from Tri Med Specialties, Inc. (Tri Med).

Tri-Med petitioned the NRC to amend its regulations "to allow for the generallicensing and/or exemption for the commercial distribution by licensed pharmaceutical manuf acturers of a capsule containing one micro Curie ( Ci) of "C-urea f or in vivo diagnostic testing." The purpose of this diagnostic test is to detect the presence of the bacterium Helicobacter pylori (H. pylori), a cause of peptic ulcers.

DISCU.SSION:

11,1996, a copy of the draf t In accordance with the SRM COMSECY 96-035 dated June rulemaking plan, recommending a generallicense approach, was provided to the Agreement States f or review and comment. The comment period closed on October 3 1996. Ten comment letters were received from Agreement States. Six States agreed with the staff's initial position to gre.nt the petition by making the "C-urea capsules CONTACT:

Sam Jones, RES 415-6198

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The Commissioners 2-  ;

available to any physician under a generallicense.' However, three States - Georgia, Illinois, and New York while agreeing that the petition should be granted, opposed the a staff's recommendation and argued that the capsules should be made available as exempt [

I material. One State, Oregon, stated that it would continue to require that any person who  ;

administers a radioactive drug be specifically licensed. .

In addition, there were some comments related to the process of Agreement State involvement in NRC rulemaking that the staff believes were addressed in SECY 96-035,  ;

and, therefore, are not addressed in the memorandum to the Commission or in the final i

' rulemaking plan. ,

Af ter considering Agreement States' comments, the staff has changed its recommendation. We now recommend that manufacturers and distributors be permitted to distribute this radioactive drug as exempt material to "any person" who is permitted to receive and use the drug under the appropriate Federal or State law governing the

- distribution and use of the drug.  ;

A_GREEMENT STATE COMMENTS ON DRAFT RULEMAKING PLAN:

in accordance with Management Directive 6.3, "The Rulemaking Process," the staff 7

draf ted a rulemaking plan in response to a petition for rulemaking submitted by Tri Med Specialties, Inc. Under the draf t plan s staff would have developed a direct final rule i amending 10 CFR Part 35 to permit, under a generallicense, any physician to administer to patients capsules containing one microcurie of C 14 as a diagnostic tool for detecting '

peptic ulcers caused by the Helicobacter pylori bacterium.

l In accordance with COMSECY-96-035 dated June 11,1996, a copy of the draft rulemaking plan was provided to the Agreement States on October 1,1996, for a 30-day period of review and comment. Comments were received from ten Agreement States. ,

Six States (Kentucky, Nebraska, Colorado, Washington, Utah, and Louisiana) supported the staff's initial position to grant the petition via a generallicense to permit physicians who are not authorized users to receive and use capsules containing 1 Ci of "C-urea.

Kentucky indicated they already have provisions for a generallicense for "in vivo" use in .

. their regulations.

One-State, Oregon indicated that it would not permit administration of the capsules under a generallicense, but would continue to require that all physicians who administer radioactive drugs, including the C-14 capsules,-be specifically licensed.

Three States, New York, Georgia and Illinois, opposed the generallicense approach recommended by the staffi Georgia and Illinois recommended that physicians who are not  :

" authorized users" be permitted to receive and use capsules containing 1 pCi of "C urea as' exempt material. Georgia argued that their burden would be increased by distributir and use under a generallicense because of reports required from distributors, invoicing of physicians for generallicense fees, and possible amendment of all of their distribution licenses. lllinois s'.ated that distribution of the capsules as exempt materialis consistent ,

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The Commissioners 3 with the NRC's technical evaluation and would ensure that physicians could have access to the capsules without a specific or generallicense, Illinois further stated that if the NRC were to require distribution and administration under a generallicense, Agreement States would need to incur the expense of modifying their regulations. lilinois seems to imply that they could avoid rulemaking if the NRC were to adopt the exemption approach.

However, as Georgia correctly observed, the exemption approach would require States to make conforming changes in their regulations as well. New York stated that they agreed that the widespread medical use of the capsules would involve no risk to the public health and safety or the environment, and would provide significant medical benefits to the population New York also stated that using a risk based regulatory approach, there is no need to regulate the capsules for their radioactive content. Further, New York argued that a generallicense is an ineffective means of regulatory controlin any case. New York also noted that the Food and Drug Administration will regulate the capsules as a drug.

There were further comments from the States addressing the process of Agreement State involvement in NRC rulemaking that the staff believes were addressed in SECY 96-035, and therefore are not addressed here. Copies of the comment letters are enclosed.

STAFF RESPONSE:

The staff initially recommended distribution of the capsules under a generallicense because if the capsules were to be distributed as an exempt material, manufacturers and distributors located in Agreement States would be required to obtain and maintain both an NRC and Agreement State license to distribute the capsules. Since the staff had concluded that there was no significant radiological safety or environmental risk, it did not intend that the generallicense would be used as a means of exercising regulatory control beyond limiting distribution to physicians. However,in light of the comments received from New York, Illinois, and Georgia, the staf f changed its position from permitting distribution to any physician under a generallicense to permitting exempt distribution to any physician. Af ter further consideration, the staff decided that manuf acturers and distributors should be permitted to distribute this radioactive drug as exempt material to any person who is permitted to receive and use the drug under the appropriate Federal or State law governing the distribution and use of the drug. Permitting exempt distribution to "any person," rather than "any physician," would avoid the need for NRC to amend its regulations if other Federal or State authorities permit the distribution and use of the radioactive drug to persons who are not physicians. Moreover, the drug will be manuf actured under a specific Part 32 license to ensure that capsules contain only one microcurie of carbon 14 and do not contain any other radioactive contaminatess POLICY ISSUES:

NRC tegulations specify that persons administering radioactive drugs containing byproduct material to patients or human research subjects must have specific authorization. Also, there are no provisions in NRC regulations f or the "in vivo" use of byproduct materia: as an exempt material. However, sn light of the above, the staff is recommer. ding the distribution of the capsu les as exempt material to any person.

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in addition, the' Commission should note that current regulations (l 30.6) addressing the use of byproduct materialin research require licensees to meet specific provisions for the .

protection of human subjects. Under the staff's recommendation, the exempt distribution  !

~

of the capsules for use in research involving humans subjects would not be authorized.

The Commission also should note that the draft rulemaking plan given to the Agreement States would explicitly limit the use of the drug to physicians. Hence, the position of the -

4 Agreement States on the staff's recommendation to not limit the use to physicians only.

but rely on FDA and State Boards of Pharmacy regulations for use is not known.

AGREEMENT STATE COMPATIBILITY:

Under the Atomic Energy Act, certain regulatory functions are reserved to the NRC.

Among these are the distribution _of exempt materials and quantities, as discussed in 10 CFR Part im. Hence, the staff's recommended approach is a Division 4 matter of ^

compatibility, with regard to the manufacture and distribution of the capsules (Part 32),

and a Division 1 matter of compatibility with regard to possession and use (Part 30). All '

Agreement States will need to adopt regulations to allow any person to receive capsules i containing 1 Ci of "C urea as an exempt material.

- The Commission should note that under the staff's initial recommendation, Oregon (and possibly other States, since not all States commented) could have continued its current practice of requiring physicians administering radioactive drugs to humans to be specifically licensed, because the generallicense amendments would have been a Division 3 matter of compatibility.

COORDINATION:

The Office of the General Counsel has reviewed this paper and has no legal objection. Tho +

Of fice of the Chief Financial Officer concurs that there will be no resource impacts beyond those currently budgeted. The Office of the Chief Information Officer concurs that there {

will be no information technology or management impacts beyond those needed for rulemaking.

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RECOMMENDATIOR )

Unless the Commission directs otherwise within 10 days from the date of this paper, I will implement the rulemaking plan and direct the staff to begin development of a proposed rule to permit the distribution of the radioactive drug as an exempt material for distribution to any person.

Hugh L. Thompson, Jr. ,

Acting Executive Director for Operations

Enclosures:

1. Final Rulemaking Plan

2. Agreement State Comment Letters t

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Rev. 01/35/97

' SECY PAPER DISTRIBU_ TION MEETING SECY POLICY

~

RULEMAKING AFFIRMATION Reviewed By ADJUDICATORY NOTATION

/ NEGATIVE CONSENT NOTE: Classified - (I) to each 5

Comission office, OGC (2),

SECY (3), & Central Files (1)

INFORMATION CLASSIFICATION EXECUTIVE DIRECTOR FOR OPERATIONS (I)

CHAIRMAN JACKSON (3) (2 for INFO)

DEPUTY EXECUTIVE DIRECTORS (5)

COMMISSIONER ROGERS (3)

ADM (I) (2)* __.

COMMISSIONER DICUS (3)

AEOD (5)

COMMISSIONER DIAZ (3)

NRR (12)

COMMISSIONER MCGAFFIGAN (3)

NMSS (5)

SECY (10-14) (80 For Mtg) _

RES (12)

OGC (17) (7 For ADJ) /

OE (I) 0FFICE OF_CAA (1/4) 01 (2)

OIG (3) __

SP (3)

PA (2)

OP (2) ,

IP (5)

SBCR (I) _

CA (2)

DOCUMENT CONTROL DESK (I)

ACRS (20)

FILES CENTER (1)

ACNW (10)

ASLBP (4)

CFO (4)

CIO (3) (4)*

RI - King of Prussia (2)

REGIONAL OFFICES: (C&R BRANCH, SECY):

RI! - Atlanta (2)

RIII - Chicago (2)

RIV - Dallas (2) _

TOTAL NUMBER OF COPIES

• If Rulemaking RETURN ORIGINAL TO: ___Yb kOM N' * '

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S RULEMAKING PLAN

i RULEMAKING PLAN TOR EXEMPT DISTRIBUTION AND USE OF A RADI0 ACTIVE DRUG CONTAINING  !

ONE MICROCURIE OF CARBON 14 UREA (PARTS 30 AND 32)

Lead Office: Office of Nuclear Regulatory Research Staff

Contact:

S. Jcnes, RES/RPHEB Concurrences: SIGNED 8/13/96 D. Morrison, RES Date SIGNED 9/19/96 C. Paperiello, NMSS Date SIGNED 9/20/96 R. Bangart, OSP Date (memo from Stuart Treby) 9/20/96 W. Olmstead, OCG Date (memo from David Meyer) 8/20/96 D. Meyer, ADM Date Approval:

R. L. Thompson, AEDO Date

I RULEMAKING PLAN Lead Office: Office of Nuclear Regulatory Research Staff

Contact:

S. Jones, RES/RPHEB Concurrences: ,.

77<4~ / 94 D. f wMorrison', RES Date (si<p 1) 4/19/46 C. Paperiello, HMSS Date I s i nn eri) 9/20/96 R. Bangart, OSP Date fMemo from stuart Trenv) 4/?0/96

7. Olmstead, OGC Date iMera free navid Meyer) 8/20/06 D. Meyer, ADM Date Approval:

J. Taylor, E00 Date

N Out EN'NS 'L2',

Office of Nuclear Regulatory Research Lead Office:

S. Jones, RES/RPHEB Staff

Contact:

Concurrences: D-~horrison, RE F ~ ~ Date

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.p R. Bangart, OSp Date T DTmstead, N C Date

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Date D, Meyer, %0M Approval: Date

1. Taylor, EDO Attacient

RULEMAKING PLAN 10 CTR PART 35 Mf0lCAL USE Of CAPSULES CONTAINING ONE HICR0 CURIE OF CARBON-14 (PRM-35-12) r Lead Office: Office of Nuclear Regulatory Research .

Staff

Contact:

S. Jones, RES/RPHEB Concurrences:

D Rorrison, RG Date C. Paperiello, NMSS Date fa sh Q l d

C 0lmstead, OGC Date D~~heye r ADH Date l

Approval: ~~

UTaylor, EDO Date l

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• [t** *'o ,,jo,, NUCLEAR REGULATORY COMMISSION l WAsHINGioN. D.c. 7066W1 o

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j ti E t i September 20, f 996  ;

g..,...f i orHet of THE GE NERA1. COUNSEL MEMORANDUM TO: David Morrison, Director ~

Office of Nuclear Reactor rch . i FROM: Stuart A. Treby " /[gf 2 Assistant General unsel for Rulemaking and Fuel Cycle

SUBJECT:

- NO LEGAL OBJECTION TO RULEMAKING PLAN FOR .

AMENDMENT OF 10 CFR PART 35 TO PROVIDE A GENERAL LICENSE FOR PHYSICIANS TO USE CAPSULES CONTAINING ONE MICROCURIE OF DIAGNOSTIC l We have reviewed the rulermking plan concerning the resolution of PRM 3512. We s recommend the addition of the following two paragraphs as a separate section entitled "OGC '

- Legal Sufficiency Analysis Demonstrating Tnat No Known Basis Exists for Legal Objection."

The proposed rulemaking would amend 10 CFR Part 35 to provide a general "

license for physicians (including those who are not " authorized users") to receive and use for diagnostic medical use capsules containing one micro- '

Curie of carbon 14 urca. OGC has reviewed the rulemaking plan, including ,

the proposed approach of a " direct final rule." No significant impediments to promulgation of a " direct final rule" drafted along the lines discussed in the plan is anticipated. OGC has not identified any environmental or Paper Work Reduction Act issues that would present significant difficulties in pursuing ,

l the proposed course of action. However, in developing actual rule language, consideration should be given to the issue whether any generallicense ,

+

conditions (such as those in former 10 CFR 35.31, "Generallicense for medical use of certain quantities of byproduct material) are appropriate.

Since the proposed direct final rulemaking plan would address resolution of PRM 3512, the statf will need to assure that appropriate procedural actions are taken to close the actions associated with that petition. These actions include specifically granting or denying the petition for rulemaking, either in '

the federal register notice associated with the rulemaking or in a separate federal register notice, and informing the petitioner of the, Commission's

[ decision. _ The detaileri procedures for responding to the rulemtking petition p

are contained in Part 11 of the Regulations Handbook (NUREG/BR 0053.

l

l. Rev.3).

CONTACTf Marjoric Rothschild. OGC -

415.1633 4

.- . -  :, . - _. a. _u ._-...._;._, .. .-

2 Marjoue Rothschild has discussed our preliminary comments on the draf t rulernaking plan (included in the attached mark up) with RES and NMSS staff and agreed that a memorandum would be transmitted formally conveying these comments.

OGC would have no legal objection to the rulemaking plan subject to the inclusion of the above lanDuage and revisions consistent with our other comments. r However, we would fita to review the Con.inission paper that will accompany this package prio. to its being forwarded to the Commission. OGC believes that all rulemaking plans should be forwarded to the Commission as negative consent papers rather than as informational papers.

Attachment:

As stated O

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i NUCLEAR REGULATORY COMMISSION j wAsuinatou, o c. xmaci

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P August 20. '996 '

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. MEMORANDUM FOR:-

udvid L. Morrison, Director

. Of fice of Nuclear. Regulatory Pasaa"@. i FROM:-

David L. Meyer, Chief b M * '

Ru18s Review and Directives Branch Division of Freedom'of Information and Publications Services  ;

Office of Administration  !

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SUBJECT:

OFFICE CONCURRENCE ON DIRECT FINAL RULEMA PLAN ENTITLED " MEDICAL USE OF CAPSULES 4" .

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-CONTAINING ONE MICROCURIE OF CARBON-1 The Office of Administration We findconcurs the rulemaking on the final plan rulemaking adequate, plan and l that amends Part 35. final rule.

Will provide support during preparation of the direct "

If you have any questions, please contact Alice Katoski, 415-6862, or' Mike Lesar on 415-7163. .

Attachment:

As stated ,

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.e David L. Morrison, Director f MEMORANDUM To:_ Office of Nucicar Regulatory Research <

TP.CM . James Li eb erman, Director [

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l CONCURRENCE ON RULEMAXING PLAN: MEDICAL USE OF i

SUBJECT:

i

. CAPSULE 9 CONTAINING ONE MICROCURIE OF CARBON-14; (14C) - (PRM-35-12) i The. Office of Enforcement (OE) concurs on the subject rulemaking  !

plan with the following comments: t How Aany capsules will a user be able to have in possession Lt.

at one time?. The'10 CFR Part 20 Appendix C limit and the 10 l r

CFR 30.71 Schedule B limit are 100 microcuries and each capsule is 1 microcurie. Does this mean that a user could l possess 199 capsules at one microcurie cach?

2. The. subject rulemaking plan allows for a user to be exempt e from having a license under 10 CFR Part 35. It is not clear whether the proposed addition of 10 CFR 35.100 will completely address the issue and whether further changes to 10 CFR Part 30 will be necessary, specifically 5 30.3, Activities requiring license. >

'Should you have any questions.regarding our comments please feel free to contact us. The staff contact for the subject rulemaking i'

plan.is Mary L. Thomas. She can be reached at 415-2739.

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August 23,1996 NOTE TO: Sam Jones, Task Leader, RES FROM: Carol Abbott, OC/DBA/PAB b A$k / [

SUBJECT:

RULEMAKING PLAN: MEDICAL USE OF CAPSULES CONTAINING ONE MICROCURIE OF CARBON 14 (PRM 3512)

As requested in David Morrison's August 14,1996 memo, OC has reviewed the subject rulemaking plan to issue a direct final rule amending 10 CFR Part 35 (adding Subpart D) to a"ow all physicians to receive and use capsules containing one microcurie of ccrbon-14 for medical use without an NRC Part 35 license. Our review of the current NRC budget shows that resources are available to proceed with the rulemaking and, because no addiJonal resources are required by NRC to implement the rule, OC finds that there are no resource-related issues associated with this rulemaking. Therefore, OC grants concurrence and recommends that the Sc301ttcn section (on page 7 of the Rulemaking Plan) be revised as follows.

8fLiiQulGC1 Resources to coniplete and imp l ament this rule are included in the current budget.

cc:

P.Rabideau OC/DBA J. Evans OC/DBA D.Corley OC/DBA/PAB P Wolfe OC/DBA/PAB R.Albright OC/DBA/ BOPS D. Howe, NMSS OC Action item: 96151 OBA Action item: 96194 PAB Action item: 619/

DBA File: NML-1.1 C:\compapr\NMSS\ carbon-14.n

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'- FINAL. RULEMAKING PLAN l

10 CFR PARTS 30 AND 32  ;

l EXEMPT DISTRIBUTION OF A RADIOACTIVE DRUG l

CONTAINING ONE MICROCURIE OF CARBON 14 UREA  ;

(PRM 3512)

BACKGROUND t t

On. 0ct ob, 6,1994, the Commission docketed a petition for ruirsaking (Docket No, PRM- l 3512) from Tri Med Specialties, Inc (Tri.Medh in a letter dated August 23,1994, Tri Med petitioned the NRC to amend its regulations "to allow for the geneol licensing and/or exemption for the commercial distribution by licensed pharmaceutical manufacturers of a

[

capsule containing one micro Curie ( Ci) of "C urea for in vivo diagnostic testing." The i  !

.-purpose of this diagnostic test is to detect the presence of the bacterium Helicobacter pyior l

.lH, pylori), a cause of peptic ulcers.

I

'uodenum that

• Peptic ulcer disease is a chronic inflammatory condition of the stomach anr' affects as many as 10% of people in the United States at some time in their hves. The disease has relatively low mortality, but it results in substantial human suffering and high economic costs " (Source: Article included as an appendir to the petition, from JAMA, July 6,1994 Vol 272, No.1, "H. pylori in Peptic Ulcer Disease-NIH Consensus Conference"),

In the petition dated August 23,1994, the petitioner stated the following: ,

Recent medical research has found that peptic ulcers are commonly caused by a bacterium called H. pylori. This bacterium lives in the '

s'omach of most ulcer suf ferers. By treating ulcer patients with antibiotics, doctors can now cure most ulcer problems.

It is therefore necessary to detect the presence of H. pylori bacteria in ulcer patients so that the new treatment can be given appropriately.

c In the past, this was done by a gastroenterologist who took biopsy samples of the stomach lining at endoscopy, a procedure which was uncomfortaule and expensive ($1000).

3 With the new tent, H. pylori can be detected non-invasively using a

."C-urea tracer. "C-urea is broken down by H. pylori to f orm labeled -

• CO, which is expired in the breath. To do the test, a doctor asks the patient to swallow the capsule with 30 mis of water. After 15 minutes the patient blows 2' liters of breath into a collection bag (a

Mylar balloon) which is mailed to a testing laboratory, it "C CO, more than twice background is present in the breath sample, then the patient must be

infected with Hl pylori.

CURRENT REGULATIONS  ?

i i 110 CFR Part 32 " Specific Domestic Licenses To Manuf acture or Transfer Certa n tems ,

Containing Byproduct Materials,". 6 32.72, "Manuf acture, preparation, of transfer for 1

. u. , , , . - _ _ - - - _ - - _ _ . . , _ _ _ . - , _ _ ,_ , . _ . - ,_ . _a.,__

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- commercial distribution of radioactive drugs containing byproduct material for medical use under Part 35," provides for commercial distribution of radioactive drugs containing byproduct material for use by persons authorized pursuant to Part 35. Thus, the regulations currently would permit Part 32 licensees to commercially distribute capsules containing 1 vCi of "C-urea to pers0ns authorized pursuant to Part 35, 10 CFR Part 35, " Medical Use of Byproduct Material," sets forth radiation safety requirements, including requirements for the training and experience of authorized user physicians to assure the safe possession and use of radioactive drugs containing byproduct material.

Existing exemptions for use of byproduct rnaterial H 6 30.14, " Exempt concentrations" and i 32.18, "Manuf acture, distribution and transfer of xempt quantities of byproduct materd.

Requirements for license," do not permit the exempt transfer of byproden material contained in any food, beverage, cosmetic, drug, or any product designed for ingestion or inhalation by, or application to, a human being.

REGULATORY ISf.'8E The regulatory issue is whether the "C-urea capsules present a sufficiently small radiation ri k that they can be safely distributed to and used by physicians who are not " authorized um i under 10 CFR Part 35.

SAFETY ANALYSIS Based on a safety analysis conducted by an NRC contractor, the staff has concluded that the human use of these capsules results in insignificant exposures as depicted below:

Maximum Exposed Routine Exposure Scenario Individual Worker administering "C- Full time worker, 8,000 Less than 0.7 mrem yr urea breath tests patients!yr Routine exposure of Patient tests negative 0.38 mremicapsule patients from "C-urea breath tests Patient tests positive 0.18 mrem / capsule

. Release of 150 pCi of "CO, Member of public in the Less than 0.0002 mrum into administration area administration area Rupture of a capsulo Skin (100 cm 2) exposed for 5.8 mrad skin dose causing sk>,n contamination one hour prior to washing 0.075 Ci skin absorption of worker or patient 0.029 mrem CEDE 2

. i i

i Pathways to the Environment I Based on an environmental report prepared by an NRC contract the staff concluded that

'I the impacts associated with any releases of "C to the surrounding environment are expected to be very small and the expected risks are minimal.

The earth's atmosphere contains an inventory of naturally occurring "C of about 3.8 milhon curies (equivalent to the activity in 3.8 trillion breath tests), which is in addition to the huge inventory of about 240 million curi s in the world's oceans. The "C released into the l

atmosphere from the use of this tett wwld mix with the globalinventory and expose the I public and other biotic components tha environment to "C intakes from inhalation, drinking water, and all possible food pathways in the same manner as naturally occurring.

- "C. The current world inventory of naturally occurring "C results in an average dose to the public of about 1.25 mrem / year, and the release of 0.6 curies of "C from the total of ' '

600,000 tests assumed to be administered annually (see the REGULATORY 4ANALYSIS section below) would result in an additional average annual dose of 2 X 10 mrom. This is far below the EPA reporting level of 1 mrem / year required under the Clean Air Act for

• routine exposures to a member of the public, or the 4 mrem / year EPA limit for public -

drinking water, in a total population of about 260 rnillion people in the U.S., the collective j

annual dose from the breath tests would be about 0.051 person rem. In addition, the doses from normal use of breath tests, or trom any accidental release of "C to the environment also are expected to be very small because the concentration of CO, released is very low and it would mix immediately with the atmosphere.

Collective Exposures to Members of the Public The small doses from naturally occurring "C are of little significance to human health and the environment, Potentiallong term impacts from widespread releases of the long lived "C (5,730 year radiological half life) from breath tests were concluded to be insignificant.

Assuming that the testing in the U.S. would increase over a period of time to an average of a million tests per year for 50 years, the collective annual dose to the U.S. population would '

- be about 5 person rem over the next 50 years. This dose is very small when compared to the annual collective dose to de U.S. population from naturally occurring "C of over <

300,000 person rem, and about 78,000,000 pers<in tem from all naturally occurring radiation. Clearly, an increase of a few person rem will not significantly change these exposures, and thus there is no expected impact from the widespread use of the breath test

--on the entice U.S. population.

COMMENTS FROM THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES ,

'( ACMUI) -

1This petition was discussed with the ACMUI at the October 1995 meeting. The ACMUI ,

' indicated that it endorsed the wide availability of this diagnostic test and that the 3 [

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- radioactive drug could be used under a general license or an exemption, whichever the NRC thought to be procedurally easier.

COMMENTS FROM THE PUBLIC The " Notice of receipt of petition for rulemaking" was published for public comment in the Federal Register on December 2,1994 (59 FR 61831L A total of 315 public comment letters, 313 supporting (mostly fum letters) and 2 opposing letters, were received.

The two letters opposinj the petition rnade the following two comments:

(1) The product should not receive an exempt status because the uncontrolled distrtute v

and application of this product could lead to significant risk to the public, and (2) Medical uses should be restricted to short lived isotopes because of disposal problems presented by long-lived isotopes.

W The staff disagrees with both comments.

(1) As shown in the " SAFETY ANALYSIS" section of this plan, the radiation dose to workers, patients, and the public is very low.

(2) As discussed in the " Pathways to the Environment" section of this plan, the impacts associated with any releases of "C to the surrounding environment are expected to be very small and the expected risks are minimal. Also, as discussed in the " Collective Exposures to Members of the Public" section of this plan, the small doses from naturally occurring "C are of little significance to human health and the environment.

Potentiallong-term impacts from widespread releases of the long-lived "C (5,730-year radiological half life) from breath tests were concluded to be insignificant.

DRAFT RULEMAKING PLAN in accordance with Management Directive 6.3,"The Rulemaking Procese," the staff dmiten a rulemaking plan in response to a petition foi rulemaking submitted by Tri Med Specialt ms Inc. Three alternati,es were considered in the draf t rulemaking plan:

Alternative 1 - Deny the petition.

Alternative 2 - Grant the petition via an exemption to permit physicians who are not " authorized users

• to receive and use capsules containing 1 pCi of "C-urca.

Alternative 3 - Grant the petition via a generallicense to permit physicians who ere not " authorized usera" to receive and use capsules containing 1 Ci of "C-urea 4

l C &

\

• Under the draf t plan, the staff would have developed a direct final rule amending 10 CFR Part 35 to permit, under a generallicense, any physician to administer to patients capsules containing one microcurie of C 14 as a diagnostic tool for detecting peptic ulcers caused by the Helicoba er pylori bacterium (Alternative 3L Distnbution of byproduct material as exempt material requires an NRC license, even in an Agreement State. Hence, manufacturert and distributors licensed by Agreement States would need ta obtain and maintain both NRC and Agreement State licenses to distobute the "C capsules as exempt material. This is not the case for byproduct material to be pnssassed and used unoer a generallicense The staf f viewed this potential duallicensmg as an unnecessary burden with no safety benefit. Therefore, the staff did not recommend distrit,ution to and use as exempt materialin the draft rulemaking plan. In terms of pubhc health and safety, either Alternative 2 or 3 could be adopted because the radiolog".,ol rist is negligible.

In accordance with COMSECY-96-035 dated June 11,1996, a copy of the draf t rulemakmg plan was provided to the Agreement States on October 1,1996, for a 30 day period of review and comment. Comments were received from ten Agreement States.

AGREEMENT STATE COMMENTS ON DRAFT RULEMAKING PLAN Six States (Kentucky, Nebraska, Colorado, Washington, Utah, and Louisiana) supported the staff's recommended approach (i.e., grant the petition, and permit physicians who are not authorized users to receivt and use capsules containing 1 pCi of "C-urea via a general-license). Kentucky indicated they already have provisions for a generallicense for "in vivo" use in their regulations.

One State, Oregon indicated that it would not permit administration of me capsules under a generallicense, but would contmue to require that all physicians who administer radioactive drugs, including the "C urea capsules, be specifically licensed.

Three States, New York. Georgia and Illinois, opposed the general license approach recommended by the statf. Georgia and Illinois recommended that physicians who are not

" authorized users" be pe :utted to receive and use capsules containing 1 Ci of "C - uma as exempt material. Georgia argued that their burden would be increased by distribution and use under a generallicense because of reports required from distributors, invoicing of physicians for generallicense fees, and possible amendment of all of their distribution licenses. Illinois stated that distribution of the capsules as exempt materialis consistent with the NRC's technical evaluatiun and would ensure that physicians could have access to the capsules veithout a specific or generallicense. Illinois further stated that if the NRC were to require distribution and administration under a generallicense, Agreement States would need to incur the expense of modifying their regulations. Illinois seems to imply that they could avoid rulemaking if the NRC were to adopt the exemption approach. However, as Georgia correctly observed, the exemption approach would require States to make conforming changes in their regulations as well, New York stated that they agreed that the widespread medical use of the capsules would involve no risk to the public health and 5

l 1

j

.s I

• safety or the envirc ment, and would provide significant medical benefits to the population.

New York also stated that using a risk based regulatory approach, there is no need to regulate the capsules for their radioactive content. Further, New York argued that a general license.is an inef fective means of regulatory control in any case. New York also noted that the Food and Drug Administration will regulate the t apsules as a drug.

RECOMMENDED APPROACH 4

The staf f agrees with the comment from New York that a general license should be used when some level of controlis desired. The staff has determined that the radiological risk at h' this drug presents such a small radiation hazard that the capsules could be treated without regard to their radioactivity. Hence, no control of the capsules is necessary for radiation safety af ter they are manufactured and distributed. In Fght of this, and in light of the comments from lilinois, and Georgia, the staff has decided not to recommen6 Jistribution and use of the "C urea capsules under a generallicense. Rather, the staff is now scommending that Part 30 be amended to permit the "C-urca capsules to be distobuted to and used by any person, without need of an NRC (or Agreement State) license, who is permitted to receive and use the drug under an appropriate Federal or State law governing the distribution and use of the drug. Thus regulation of receipt and use of the drug will be lef t to other Federal and State agencies with the responsibility and authority to regulate The staff drugs (as is the case for other drugs that do not contain byproduct materials).

believes that permitting exe ' ct receipt of the capsules by "any person who is permitted to receive and use the drug ur' r an appropriate Federal or State law," rather than limiting receipt and use to physicians only will provide any controls needed for regulation of the capsules as a drug, and avoid the need for NRC to amend its regulations if other Federal or State agencies permit under their authority the distribution and use the radioactive drug to '

persons who are not physicians.

The staff believes that NRC should require the drug to be manuf actured under a specific Part 32 license to en u re that capsules contain only one microcurie of carbon-14 and do not contain any other raoioactive contaminates. Hence, conforroing amendments would be made to Part 32 to provide requirements for a specific license to manufacture, process.

produce, package, repackage. or transfer capsulcs containing one microcurie of "C-urea, as a radioactive drug, to be distributed as an exempt matenal to any person fT *in vivo" diagnostic testing. Licensees distnbuting the radioactive drug as an exempt material would not be relieved from other applicable Federal (e.g., FDA) or State drug manuf acturing and distribution requirements.

PREllMINARY REGULATORY ANALYSIS in the letter dated August 23,1994, the petitioner stated, If exempted, the C 14 breath test could be done by most doctors for less than $100 cost to the patient. This is a considerable savings over endoscopy and biopsy (S1000).

6

)

In a letter on November 30,1994, the petitioner stated:

.. The test is 95% accurate and quite inexpensive because of its simplicity. The test would permit doctors to determine easily whether or not ulcer patients have been cured of their infection. By providing the public with an inexpensive, easily accessible diagnostic test, more individuals would be accurately diagnosed and treated for their H. pylori infection. This would save the United States an estimated $500 million per annum over conventional therapy.

Tri-Med estimates annual benefits to be on the order of $500 million/ year. This assumes approximately 600,000 "C-urea breath tests / year, at an average cost of $100, in lieu of performing endoscopy at an average cost of $1000/ test. It assumes that the lower cost and greater availability of an unregulated breath test would result in a complete substitute for endoscopy. Tri-Med's benefit analysis provides a measure of the total benefits associated with the test and does not focus on the incremental benefits of administering the test pursuant to 10 CFR 35.100 regulation (status que) versus releasing the test to all physicians (NRC licensed and non licensed alike). Implicit in Tri Med's estimated annual benefits is the presumption that none of these "C tests and corresponding savings would accrue if the petition were denied. In reality, under the status quo, the test would be available ano administered by physicians or clinics holding a license under NRC's Part 35.

Further, Tri-Med's estimate did not allow for the bstitution of other non-invasive tests (e.g., serological test for igg antibod~es te H. pylori antigens) for both endoscopy and "C-urea tests in addition, wire service articles dated September 19,1996, stated that the FDA has approved a non radiological diagnostic breath test using "C for detecting the presence of H. pylori inf ections.

The staf f's beneht analysis focuses on the incremental benefits of granting relief based on the petition. The analysis looks solely at changes relative to the base case or status quo. In this analysis, the comparison is between regulated and unregulated "C-urea breath tests, not unregulated "C-urea breath tests and endoscopies or other non invasive tests. For the purposes of this regulatory analysis, the staff assumes that the same number of breath tests (i.e., 600,000 tests) will be administered regardless of the level of NRC regulatory control.

This view is predicated on the belief that each physician's primary motivation is to provide the best possible care to his or her patients if the breath test is judged preferable to endoscopy, or other procedure, any physician not authorized to use the test will refer his or her patient to authonzed users who could perform the test under existing NRC regulations This appears fully consistent with standard medical practice, whereby patients are referred routinely to laboratories and specialists for a wide array of tests and procedures.

In the NRC's analysis, the benefits of adopting the petition accrue as a result of reduced patient cost and reduced health care cost resulting from the elimination of the need for referrals from a physician who is not an authorized user (e.g., gastrointestinal specialist).

There would also be some regulatory savings because the NPC would not have to expend resources reviewing new applications for specific medical use licenses. However, the NRC savings would be small because the staff expects that few physicians who are not authorized users would apply for a specific NRC bcense for use of this one prosuct.

7 1

l. .

t The stall's beneSt calculation is based on the assumption that a significant portion of the 600,000 patients would receive the "C breath test from physicians who are not authorized user.a "e.g., gastrointestinal specialists) instead of authorized users (e.g., nuclear medicine specialists). The actual savings would be dependent on the number of tests ultimately administered by physicians who are not authorized users, thereby eliminating the need for a referral.

The annual savings could be as high as approximately $20 million if there was a complete shif t of the administration of the tests from physicians who are authorized users (i.e., bam case) to physicians who are not authorized users.

The basis for this estirrate is as follows.

Assuming adoption of the petition eliminates the need for 600,000 referrals patient savings in averted travel expenses (transportation and personal time incurred with medical referral) '

would be:

Assuming round trip of 20 miles @ $0.25/ mile. and personal time of 0 5/ hours / trip valued at $25.00/ hour 600,000 trips / year x (20 miles / trip x $0.25/ mile + 0.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> / trip x $25.00! hour) =

$10.5 millionlyear Health Care Savings in averted administrative expenses (administrative costs incurred with medical referral) would be:

600.000 patients / year x $19.00/ patient = $11.4 million/ year Assuming $19.00 (administrative cost / patient) as the differential between the cost of an office visit to a general f amily practice physician by an established patient

($45.90), and the cost to a new patient ($64.90 per visit) for completion of new patient paperwork, reviewing health history, maintaining medical rv uds, etc. The patient who is referred to an authorized user (e.g., nuclear medic +,. opecialist) for the "C urea breath test would most likely be a new patient for the authorized user.

Total Savings:

$10.5 millionlyear + $11.4 millionlyear = $ 21.9 millionlyear Alternatively, it only 200,000 or 400,000 of the 600.000 tests were performed by a phytician who is not an authorized user, the annual cost savings would be approximately $7 million/ year and $15 million/ year, respectively.

8

I l

LCOMPARISON OF ALTERNATIVES Alternative 1 - Deny the Petition This alternative would maintain the status quo. Only physicians who are authorized users under Part 35 would be allowed to possess and administer the "C-urea test. Any physician could apply to become an authorized user. However, the NRC expects few physicians would apply for a Part 35 license for the sole purpo ;e of using such capsules because of the requirement for training and experience and the essociated costs of obtaining and maintaining a Part 35 license. Alternatively, physicians who are not authorized users could refer their patients to physicians who are authorized users to undergo the diagnostic test, but this would add expense, inconvenience, and delay to an otherwise straight-forward procedure.

Alternative 2 - Grant the petition to permit the "C-urea capsules to be distributed to and used by any person, without need of an NRC (or Agreement State) license, who is permitted to receive and use the drug under an appropriate Federal or State law governing the distribution and use of the drug.

Parts 30 and 32 would be amended to permit the manufacture and distribution of capsules containing one microcune of "C-urea as an exempt matenal to any person. The staff has determined that the radioactive component of this drug presents a minimal radiation risk and, therefore, regulatory control of the human use of capsuiod, for radiation safety is not necessary.

Alternative 3 - Grant the petition via a general license to permit physicians who are not

" authorized users" to receive and use capsules containing 1 Ci of "C-urea for in vivo diagnostic testing.

This alternative would permit any physician to receWe and use capsules containing 1 Ci "C urea for human use under a generallicense. The health and safety concerns for this alternative are the same as Alternative 2. However, if this alternative were adopted, there could be a burden to those Agreement States and Agreement State licensees in States that assess licensing or registration fees for general license holders.

RECOMMENDED COURSE OF ACTION The staff recommends proceeding with a rulemaking amending Parts 30 and 32 in conformance with Alternative 2 for the following reasons:

• Health and Safety Based upon the analysis of the radiologicalimpacts discussed above, there do not appear to be any safety or technical reasons why the capsules, breath test materials, 9

l f

• J I

counting fluids and vials, and urine from patients cannot be treated without regard to their radioactivity.

• Avoided Costs Under Alternative 1, physicians who are not authorized users would have to refer patients to authorized users to undergo the diagnostic test. These referrals and attendant expense could be avoided under either Al'ernatives 2 or Alternative 3.

However, compared with Alternative 3, Alternative 2 appears to be less burden for Agreement States and their licensees.

AGREEMENT STATE IMPLEMENTATION Rules pertaining to the distribution of products to persons exempt from NRC requirements fallinto the class of regulatory functions reserved to the NRC pursuant to the AEA and delineated in 10 CFR Part 150. Therefore, the staff's recommended amendment to Part 32 pertaining to the menuf acture and distribution of capsules containing 1 Ci of "C urea for "in vivo" diagnostic testing by persons exempt from licensing would be a Division 4 matter of compatibihty The amendment to Part 30 would be a Division 1 matter of compatibility since Agreement States would need to conform their regulations to recognize that possession and use of "C urea capsules is exempt from licensing. States (e.g., Oregon, and possibly others) would not be able to require that physicians administering radioactive drugs to huinans be specifically or generally licensed.

OGC LEGAL SUFFICIENCY ANALYSIS DEMONSTRATING THAT NO KNOWN BASIS EXISTS FOR LEGAL OBJECTION OGC has reviewed the rulemaking plan and has not identified any environmentalissues that would present significant dif ficulties in pursuing the proposed rule.

Since this rulemaking would address the resolutior, of PRM-3512, the staf f will need to ensure that appropnate procedural actions are taken to close the actions associated w:th that petition. These actions include specifically granting or denying the petition f or rulemaking, either in the Federal Register notice associated with the rulemaking or in a separate Federal Register notice, and inf orming the petitioner of the Commission's decision.

The detailed procedures for responding to the rulemaking petition are contained in Part 11 of the Regulations Handbook (NUREG/BR OO53, Rev. 3).

ASSESSMENT OF LIKELY IMPACTS ON NRC AND AGREEMENT STATE LICENSEES This rulemaking would not result in any additional regu'.atory burden to NRC medical use bcensees. Authorized users would continue to be authorized to receive and use this product for medical use.

10

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__----_ ~ "~ - _ .,.

l t .

SUPPORTING UOCUMENTS A regulatory analysis, an environmental assessment, and an OMB information collection

- approval package will be provided for tnis rulemaking.

RESOURCES Resources to complete and implement this rule are included in the current budget.

LEAD OFFICE STAFF AND STAFF FROM SUPPORTING OFFICES Staff:levnLWorkingliroup Cnnnurting-. Official RES Sam Jones Bill M. Morris NMSS Donna Beth Howe Donald A. Cool OGC Marjorie Rothschild Stuart A. Treby OSP - Lloyd Bolling Richard L. Bangart ADM - Mike Lesar David L. Meyer ,

STEERING GROUPS / WORKING GROUP There is no need for a steering group for this rulemaking. The Working Group is identified above.

ENHANCED PUBLIC PARTICIPATION This rulemaking will be placed on the electronic bulletin board at FedWorld and will also be published in the Federal Register.

EDO OR COMMISSION ISSUANCE Because the amendment involves a policy issue (i.e., the capsules would be distributed to any person who would be exempt from NRC regulations), it is recommended that the Commission issue the rule.

11

SCHEDU.LE Proposed Rule: Weeks from the dato EDO/Comm approves the Rulemaking plan Send proposed rule to office for 2 weeks .

concurrence Send proposed rule to EDO 6 weeks Send proposed rule to Commission 8 weeks Receive Commission approval 10 weeks Pubhsh in the Federal Register for a 75 day 13 weeks pubhc comment period; and submit information collection approval package to OMB 12 1

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4 AGREEMENT STATE COMMENT LETTERS

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CABINET FOR REALTH SERVICES- - h-O ,

COMMONDT.ALTHOF KDm;CKY FRANKFORT 40621000t

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f IEPARTwenroaresuCHr.A1.m October 4, 199e LLOYD BOLLING U S NUCLEAR REGULATORY COMMISSION OFFICE OF STATE PROGRAMS WASHINGTON D C 20555

Dear Mr. Bolling:

Kentucky has no opposition to allowing use of carbon-14 in one microcurie amounts under a general license as proposed in the rulemaking plan for 10 CFR Part 35 (SP-96-107).

We already have provisions for a general This license for D vivo regulation usebe would in our regulations under 902 KAR 100:050. authori::ed required to In bethe amended to include carbon-14 as an interim of revising the regulation, w<3 would A material.

allow the use under a general license as a licensing policy.

form is required to be submitted for this license; however, only aNo add signature is required. A fee is charged, on an submitted, thus a review is not required.

annual basis, for a general license.

Sincerely.

.~x: AW icki D. Jeffs, Supervisor Radioactive Materials Unit 8-hO t.D 2

w S f- A- +

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Frems 'Jcyce Oavinson cdavidscnanredec.nrt. state,ne.us>

To WND1. 'a*NP 9 ( L ab )

Date: 10/17/96-11:32pm'

Subject:

Draft Rulen.aking Plan t10.0FR Part 35; Hi Lloyd:

I send you an E-Mail saying that we favor l

Brian Hearty Altert asked that.tive 3 and concur that NRC should proceed directly-to final ru e.

Should you have any questions regarding this E-mail message please contact Brian or me at my E mail address or call (402) 471 2168.

Have a nice dayI!!

Joyce

JAY.E JACOB; <we:ac:c Ismtpgate . dpr.e . sta t e . :: . us a From:

To: 'CO: CG9 1abi .

Date: 10/21/96 6:56pm Subjects Draft Rule for C 14 capsules Greetings I.loyd The proposed rule re " Medical Use of Capusles COnta2ning Oneand should go PRM-35 ;;, appears appropr2a.a, Microcurie of Carbon 14*,

forward.

If you have any questions, please call.

Jake udi . internet3 (" rquillinasmtpgate . dphe . state . co .us" .

CC:

~ ~ - - " - " " - - - " - ~ - . . - _ _ , _ _ _ _ _ - - - - - ^ " " - - . - . _ _ _ _ _ _ _, _ "^

1 I

l From: Fra:ee, Cerry sicf13:3Lhuc.dch.'.3.get.

Tot hi.'D I . *a7 P 9 : l a b ;

Date: 10 f ;; / 96 B:23pm

Subject:

SP 96 107 To: Lloyd Bolling, OSP, NRC This is our response to your request for ccmments on the "Oraft Rulemaking 1, 1996. Specifically, the Plan for 10 CFR 35" received by FAX en October " Medic- ' t'-= cf Capsules draf_ elan, in " Pre decisional" form, concerns Containing One Microcurie of Carbon-14" and is based on PRM-35-12.

We have two summary comments: 1) we support alternative 3 which would and establish a " general license" for use of this low risk diagnostic test;

2) we believe " parallel rulemaking" with the CRCPD should have beenfinal rule".

considered rather than jumr ry immediately to a " direct d

for "in vitro" testing (10 CFR 31.11) is A general license similar to that This includes a registratien considered appropriate for this rulemaking. for a wide range of crocess. This will provide a method of " authorization" fee is required),

physician users; will be low cost (where a registrationlicensed by an Agreement allows the manufacturers of the capsule to be fullyregulatory agency with some in States if located therein: and provides the plus a database for later use knowledge of usage within its jurisdictiondegree of control over this new evaluating a further relaxation in the product (for instance, eliminating the registration requirement)

State compatibility We agree with the choice of " Divisionshould 3" for Agreement also be provided to relate it to although a corresponding assessment procedures for the the new classification expected under the implementationCompatibility of AgreementState Final Policy Statement on the Adequacy and Programs.

Finally, while we support speedy resolution of PRMs and agency initiated NRC has rulemaking efforts, we ha' .ver supported the level of secrecy that In the initial devising, and employed phase, in the various pr...es of its rulemaking ef f ort .it allows NRC otaff to fixate o to establish themselves At the in afinal narrowly phase, defined position it results in the Commission must be defended. tries to reflect the scope of an issue and receiving a " decision" paper that interested parties as the varying and of ten complex positions of otherrulemaking should be an open interpreted by NRC staf f alone . We believe what your rationalization, the process throughout its course and, no matterviewed as " secrecy" and simply feeds the use of " Pre-decisional" documents is come Agreement States' distrust of the public's, the licensees' and, alas,the Commission seek independent views on NRC's actions. We recommend that the NRC staff publish (and/or actively issues brought before it and that audience) issues and alternatives, responses and draft each in distribute to a rule langzage, and wideproposed final rule language for public comment,One step toward this turn, to be sure- there is adequate public involvement.

goal is working with CRCPD in the proposed

• parallel rulemaking" process.

If you have any questions abo' t..................... this e-mail:

This message from: Terry Frizee Quick ways to reach me:

Voice .=300-753-3461 FAX = 360-753-1496 Also, visit our Home Page at

--> ht tp : / / www .doh .wa . gov /chp / rp

.--. -- _ - _ - _ _ - _ - - - _ _ _ _ _ _ _ __ -~^ ^ -

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Oraig Jcnes <c; nesideg. state.;;. usa Prem To W:01.WNP9ilac' 10/24/96 12:17pm Data:

Subject:

Occeents SP-96 1D?

Hi Lloyd, have reviewed the

14. We A nu:rter of staff witnin rulemaking plan for medical use of capsules containing carbon- ::: . the D2.2s2cn of P.adiatienplan0 ntrcl idocket draft support cptaon Thanks 3 as c.utI:n:d in the pre dec: sional rulemak:

for the early opportun2ty to cor.?ent.

PP& 35 12),

ud1. inte rne t3 ( "BSINCLAI3deg . s tate .ut .us " )

CC:

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' Albany. NY l2:40 a O

4 m y 7 October 14.1996 2 h

Ifo Mr. Lloyd Bolling Office of State Programs USNRC Mail Stop 3 D 23 Washington, D.C. 20555 RE: Agreement States Lettei SP-96-107 Drafi Rulemaking Plan 10 CFR Part 35

Dear Mr. Bolling:

vetor's conclusion that the widespread medical use of We agree with NRf e of carbon-14 would involve no risk to public health and capsules containing one mt safety or the environment, and would provide signincant medical benefits to Using a risk based regulatory approach, there is, therefore, no need to re product for its radioactive content. This is especially (GL).

The only reasons given by NRC for not exempting the recipients of this pro all further regulation, is that manufacturers (and initial distributors other than m would have to obtain NRC licenses authorizing exempt distribution, and this would imp regulatory burden 'on NRC.

Since it appears that there is only one manufacturer of this product at th this would seem to be an inconsequential burden. The draft rulemaking pian also there would be no regulatory burden resulting from a GL designation, and states that us under a GL would not haze to register with NRC, as they did under the GL that us Part 35 and Agreement State regulations. However, on page 11 of the plan it developing the actual rule language, consideration should be given to the issu general license conditions (such as those in the former 10 CFR 35.31," Ge Medical Use of Certain Quantities of Byproduct Material") are appropriate." Therefo Posu'bility of a regulatory burden on users of the product, and on regulator This makes the comparison of regulatory attematives in the plan

' GL is unknown at this time

. invalid.

SP4-4

9. q px -

FM: 516 457-5S45

. Tclephone: 519-457. t202

- - . 2 General Licenses always contain terms and conditions, since they are a means of.

exerting regulatory control over the users of a GL product. However, they are an ineffective regulatory tool that attempts to establish a gray area between exemption and specific licensing, and ?!s often leads to inadequate control ever hazardous radiation sources and over-regulation of trivial radiation sources.

4 Having concluded that this product needs no regulatory control after its distribution, it '

makes no sense to license end users in any way. If decisions on whether a product should be distributed as exempt are to be based on the regulatory burden on NRC, rather than on an.- '

appropriate risk-benefit analysis, we will distort our entire regulatory system.

4 The product should clearly be exempt, and NRC's process re-engineering group shou!d ensure a stnamlined exempt distribution licensing process for it.

Sincerely, 6 i Rita Aldrich Principal Radiophysicist -

. RA:Jmp 1

, > ~--

a-- --w -

From: spell, 31;; <b:;;stdeg. state..a.us>

To Fratee, Terry < t:f 0 3 : 3 thut . dth . wa ;t'z>

Date: 10<23 96 12: 12pm

Subject:

RE: 3P 36.;;;

Tc the final paragraph.

early in ye support your positten en this matter completelyto invclve the regu;ated ecmmun 7 would add, "It wouldn't hurt the rulemaking process. The result will be easier for those regulaticns, and ::

accept." we tried this an develeping the wal; Icgging their views were adequately worked well. The regulated commun2ty felt addressed.

CULater.... .

Bill From: Frazee, Terry To: lab Cc: phl; wpo{dhec4005. columbia 34.autryvr); rratliff; rquillin; 103075.1375; ray.d. parts; egrad.bsinclai; paul. merges; mmobley; jvolpe; dm0020; dflater; teff100w- davidson; ccmail.kwangler; kxr01%albnydh2.bitnet; rrknycbrh; k allen; tom hill; hwl.eba21ey; gdwa 3a; robert.schell; hallisey; bill s; ~ -

~

rkelley

Subject:

SP 96 107 Date: Tuesday, October : , 1996 5:23PM To: Lloyd Bolling, CSP, NRC for comments on the " Draft 1996.

This is our response to your request 35" received by FAX on October 1, Rulemaking Plan for 10 CFR form, concerns In " Pre-decisional" and is based Specifically, the draft plan." Medical Use of Capsules Centainlag One Microcurte of Carbon on PRM-35 10

1) we support alternative 3 which would and 2)

We have two establish summarylicense" a " general comments: for use of this low risk diagnostic test;ld have been considere we believe aparallel rulemaking" with the CRCPD shoufinal rule" rather than jumping immediately to a " direct for "in vitro" testing (10 CFR 31.11) is A general license similar to that This includes a registration for a wide range of considered process. appropriate for this rulemaking.This will provide a method o by an Agreement physician-users; will be low cost allows the manufacturers of the capsule to be tully licensedand States if located therein; in provides th knowledge of usage within its jurisdiction plus a database for later use i product evaluating a further relaxation in the degree of control over th s new (for instance, eliminating the registration requirement) for Agreement State compatibility to We agree with the choice of " Division 3"should also be providededures to relate foritthe although a corresponding assessmentthe new classification expected under the implem Final Policy. Statement on the Adequacy -~s. and

' Compatibility of Agreement State Prog Finally, while'we support speedy resolution cf PPMs and agency initiated NRC has

-rulemaking efforts, we have never supported the level of secrecy In the that initial and employed phase, in the_various phases of its rulemaking effort.it hen allows feel NRC to establish themselves in a narrowly defined position which they tresults in the Commissio must be defended.

At the final phase, it the scope of an issue and the~ varying d by NRC a." decision" paper that tries to reflectand of ten complex positions of other intere

Dd) (5Pcq) Q

. -~ .

e l S IS DEPARTME . ._

R SAFETY Q.

gg. g.g . l 10, RK _VE l

SP s Jim Edgar \2r . ((62704

)

Thomas W. Orteiger Director l

Govemor '

y .. ' l l

October 28,1996 e

Paul Lohaus $

Deputy Director  %

Office of State Programs

&o Mail Stop 3D23 ,$

Office of Governmental and Public Affairs U.S. Nuclear Regulatory Comrmssion g Washington, D.C. 20555  %

Re: Draft Rulemaking Plan entitled " Medical Use of Capsules Containing One Microcurie of Cubon-14."

Dear Mr. Lohaus:

The Illinois Department of Nuclear Safety (the Department) hereby submits its comments on the referenced rulemaking plan. The proposed rulemaking represents chanres to 10 CFR Part 35 to authorize the commercial distributi micro-Curie C-14 capsule for in-vivo diar,nostic testing for peptic ulcers under a General License.

The Department believes the best option is Alternative 2, in which the NRC would only need to issue a license for the manufacture and distribution of the C-Distribution to persons exempt is capsules in accordance with 10 CFR Part 32 consistent with the NRC's technical evaluation and would ensure tha.t physicians c have access to this material without a specific or generallicense. The number of new manufacturer / distributor exempt distribution licenses will be far fewer than the num of licennes (or registrations) that would be issued nationwide to physicians who potentially use this material.

Implementation of Alternative 3 would requite the NRC and each of the 2 Agreement States to have costly rulemaking proccMings to add a general license the regulations of each agency. Generallicenws should be used only when of control is desired for the product. The NRC's technical analysis indicates that no controls are warranted, so Alternative 2 is appropriate and the least costly approach GP-Pt M u.ac-r

Paul Lohaus Page 2- .

October 28,1996 The Department appreciates the opportunity to provide its perspective on draft rulemaking plan. - If you have questions regarding these i'. ems, please contact me or Steven C. Collins at (217) 785-9948.

ince i

^N Thomas W. On i r Director TWO:meb cc: Jim Lynch State Agreements Officer 4

\

J l

.'_m_. '

Octoter 29,1995 :

Mr. Lloyd Bolkng,~

Ottice of State Progruns USNRC:

. MailStop 3 0 23

- Washington 11C- 20555

Dear Mr. Bolling:

Thicis in response to All Agreement States Letter SP 96107 Draft Bals Making Plan 10 support Altemative 2. Although inis places an initial regulatory burden on the NRC, it re distributors and the Agreement States. This should not place any undue regulatory burden on Agr licensees wishing to distribute the'one microcurie carbon 14 capsules. The capsules ca.1 b taanufacturer to physicians. As there does not appear to be any radiologicalimpacts on pat i the analyzing laboratory would not need to be licensed. Agreement States are always amen

- cf compatibility. Therefore, we consider the regulatory burden to be minimal to include the ex rulemaking.-

' We do not agree with Alternative 3, granting a generallicense.: Our regulatory burden Alternative 3. Although Altemative 3 may not cause a regulatory burden on NRC. it willimpos to Georgia licensees, the distributors of the capsules, and will result in generallicense fee physicians, i

The sp'scific regulatory burden on Georgia licensees would be as follows:

1.

We would continue to require the distributor tc, send us a repo't quarterly as required for distribution under a generallicense.

2.

We will be required to invoice the physicians for the generf licensee fee, which wo to a person receiving under an exempt distnbution license.

3; We may have to amend all of our distribution licenses to allow for distribution of th general license. This will add an additional cost to our licensees for the ame

- not be csused by exempt distribution, i

We recommend proceeding with a direct final rule amending Part 35 in conf armance w y

Sincerely

. Thomas E. Hill, Manager P.adioactive Materials Program LTEHlkic l_

h s 6.y y y g-9 + . , - v --+, .

gn-

- The Commissioners 5 RECOMMENDATION:

Unless the Commission directs otherwise within 10 days 'from the date of this paper [I will

~ implement the rulemaking plan and direct the staff to begin development Of a proposed

. rule to permit the distribution of the radioactive drug as an exempt material for distribution to any person.

Hugh L. Thompson, Jr.

Acting Executive Director for Operations

Enclosures:

1. Final Rulemaking Plan

2. Agreement State Comment Letters Distribution:

CTrottier/RPHEB RF, Central File, FCostanzi, LRiani,

CGallagher, DMendiola, ATse NMSS: LCamper, DBHowe; OGC: MRothschild, STreby:

- OSP: LBolling EDO r/f

• See previous concurrence

... . m c . m, . .c .. v . m, . w- . v . = =,

i. . .,

D/DRA/RES D/RES OGC DfricE: DRA/MPNES DRA/RPMES anorris* Dmocrison Siretyy*

wmE: SJanes*: et Cirottier6 11/18/96 1/27/97 1/29/97 1/24/97 ]

DATEt 11/15/96 IMNS/NMSS OsP CFO CIO EDO OFFICE: ,

RBengart' RScroggine* OCrenford* HLThompson NAME: ' DCool*

1/24/97 1123/97 1/24/97 il /97 DATE: .1/23/97

OFFICIAL RECORD COPY RES FILE CODE NO : 3A 3

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The Commissioners F

l s

Agreement States will need to adopt regulations to allow any person to receive capsules containing 1 Ci of "C urea as an exempt material.

The Commission should note that under the staff's initial recommendation. Oregon (and possibly other States, since not all States commented) could have continued its current practice of requiring physicians administering radioactive drugs to humans to be specifically licensed, because the generallicense amendments would have been a Division 3 matter of compatibility.

COORDINATION The Office of the General Counsel has reviewed this memorandum and has no legal objection. The Of fice of the Chief Financial Officer concurs that there will be no resource impacts beyond those currently budgeted. The Office of the Chief Information Officer concurs that there will be no information technology or management impacts beyond those needed for ruiomaking.

NOTE:

Unless the Commission directs otherwise within 10 days from the date of this memorandum, I will approve the rulemaking plan and direct the staff to begin development of a proposed rule to permit the distribution of the radioactive drug as an exempt material fer distribution to any person.

Enclosures:

1. Final Rulemaking Plan

2. Agreement State Comment Letters cc: OGC, OCA. OlP, CFO. CIO, SECY Distribution:

CTrottier/RPHEB RF, Central File, FCostana. LRiani, CGallagher. DMendiota. ATse, EJordan NMSS: LCamper. DBHowe; GGC: MRothschild. STreby:

OSP: LBolling -

DOCUMENT NAME: c:\tse\trimed. cat

• See previous concurrences

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D/DRA/RES D/RES OGC l OF FICE : DRA/RPHtB DRA/RPHES l MAME: $ Jones *: tb C1rottier* BMorris* DMorr (

Streby*

1/27/97 j1/ 97 1/24/97

, DATEt 11/15/ % 11/18/ %

osP CFO CIO EDO OFFICE: IMNSINMsS i Rscroggins' GCranford' HLThompson NAME: DCoot* RBangart' 112419 7 il 19 7 112 3197 il24J97 1123/97

{ DATE:

OFFICIAL RECORD copy RES FILE CODE NO.: 3A 3

14 - ,

The Commission:rs -

[

The Commission should note that under the staff's initial recommendation, Oregon (and ~

pussibly.other Statesi since not all States commented) could have continued its current

. practice of requiring physicians administering' radioactive drugs to humans to be

. specifically licensed, because the generallicense amendments would have been a -

Division 3 matter of compatibility.

COORDINATlON The Office of the General Counsel has reviewed this memorandum and has no legal-.'

objection. The Office of the Chief Financial Officer concurs that there will be no rescurce

~

. impacts beyond those currently budgeted, The Office of the Chief information Officer

~

concurs that there will be no information technology or management impacts beyond those.  ;

- needed for rulemaking.

NOTE:

Unless the Commission directs othm;/ise within 10 days from the date of this- -

Cmemorandum, I will. approve the rulemaking plan and direct the staff to begin development of a proposed rule to permit the distribution of the radioactive drug as an exempt material' for distribu' ion to any person.

_ Attachments:

1. Final Rulemaking Plan -

2. Agreement State Comment Letters .

cc: 'OGC, OCA, OIP, CFO, CIO, SECY Distribution: -

CTrottier/RPHEB RF, Central File, FCostanzi, LRiani,

, CGallagher, DMendiola, ATse NMSS: LCamper, DBHowe; OGC: MRothschild, STreby:

' OSP: LBolling DOCUMENT NAME: o:\tse\trimed. cat -' See previous conc. .

v. . .,

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!: OfficEt: ORA /RPhEB DRA/RPHES [ 0/RES OGC k in DNorrison Sireer NAME: $ Jones *t-- nb Cirottier*

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.NAME: Dcoot * ~ RBangert' -

1124/97 1123/97 1/24!97 11_- 19 7 - .

DATE: 1/23/97 OFFICIA. RECORD COPY RES FILE CODE ht 3A-3

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l .

The Commissioners 4 AGREEMENT STATE COMPATIBillTY Under the Atomic Energy Act, certain regulatory functions are reserved to the NRC.

Among these are the distribution of exempt materials and quantities, as discussed in 10 CFR Part 150. Hence, the staff's recommended approach is a Division 4 matter of compatibility, vith regard to the manufacture and distribution of the capsules (Pa*t 32),

~~

and a Division 1 matter of compatibility with regard to posserdon and use (Part 30). All Agreement States will need to adopt regulations to allow any person to receive capsules containing 1 Cl of "C-urea as an exempt quantity.

The Commission should note that under the staff's initial recommendation Oregon (and possibly other States, since not all States commented) could have continued its current practice of requiring physicians administering radioactive drugs to humans to be specifically licensed, because the generallicense amendments would have been a Division 3 matter of compatibility.

OGC COORDINATION The Office of the General Counsel has reviewed this memorandum and has no legal objection.

NOTE:

Unless the Commission directs otherwise within 10 days from the date of this memorandum, I will approve the rulemaking plan and direct the staff to begin development of a direct final rule to permit the d'stribution of the radioactive drug as en exempt quantity for distribution to and use by any person.

Attachments: 1. Final Rulemaking Plan

2. Agreement State Comment Letters cc: OGC, OCA, OlP, SECY

~ .tribution:

CTrottier/RPHEB RF, Contral file, FCostanzi, LRiani, CGallagher, DMendiola, ATse NMSS: LCamper, DBHowe; OGC: MRothschild, STreby; OSP: LBolling DOCUMENT NAME: o:\tse\trimed. cat

• See previous conc.

v.,.c.,,..e..,.tw.. . - nt..ne..i..am. m c .c ,, m t u.c%.m.ne..u... a .c..v.,m

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r,RA/R$ttB DRA/RPHER A D/RES OFfttit l NAME: SJones': nb Cirottier* f 9%rris DMorrison l DATE: 11/15/96 11/18/96 f 1/ 17 /97 k1/ 197 OFFICE: OGC IMNSJ p[ ,

DSP EDo

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NAME: STreby DCoolf,y,1 i RBancart ,

DATE:- il l97 11 k h 197 il /97 1/ (97 o m ci7 m c w c m RES FILE CODE Mo.: 3A 3

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.t 4

The Commissioners Agreement States will need to adopt regulations to allow any person to receiv containing 1 Ci of "C-urea as an exempt quantity.

be staff's initial recommendation, Oregon (and The Commission should note that possibly other States, since not all uates comtnented) could have continued its c practice of requiring physicians administering radioactive drugs to humans to be specifically licinsed, because the generallicense amendments would have been a Division 3 matter of compatibility.

COORDINATION The Office of the Genel Counsel has reviewed this memorandum and has no lega objection. The Office of the Chief Financial Officer concuss that there will be no impacts beyond those currently budgeted. The Office of the Chief Information concurs that there will be no information technology or management impacts b needed for rufemaking.

NOTE:

Unless the Commission directs otherwise within 10 days from the date of this memorandum, I will approve the rulemaking plan and direct the staff to begin de of a proposed rule to permit the distribution of the radioactive drug as an ex for distribution to any person.

Attachments:

1. Final Rulemaking Plan

2. Agreement State Comment Letters cc: OGC, OCA OlP, CFO, CIO, SECY Distribution:

CTrottier/RPHEB RF, Central File, FCostanzi, LRiani, CGal'agher. DMendiola. ATseOGC: MRothschild, STreby OSP: LBolling NMSS: LCamper, DBHowe:

• Sea previous conc.

DOCUMENT NAME: o:\tse\tiimed. cat m.oi .nuum.eu.ne.w.. a - ., om

.,,.ni, n.w. ,n m. ... c c..,

T. ..c .. . ...y ., m,. = he co.y an.cmenu. net.sut.. *N* OCC 0 /DR A /RE S D/RES ORA /RPHEB i OFFICE: ORA /RPHE9 Streby BMorris DMorrison 5 Jones *: nb Cirottier*

NAME:

1/ /97 }1/ 97 f1/ /97 11/15/96 j11/18/96: m =.

i

[OAtti _

Eco CFO Clo IMNS/NMSS - oSP f , l j OFFICE: _ - p g)

RScroggins GCranford ] K. Thompson _

R8angart NAME: oCool _ _

1! /97 1/ 19 7 _

I f ') (97 j 1/ 19 7 _

ATE: 1/ 19 7 OTFiC6AL RECORD CMY RES RILE CODE Noa 3 A 3

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4 The Commissioners i Agreement States will need to adopt regulations to allow any person to receive capsu containing 1 Ci of "C-urea as an exempt quantity.

The Commission should note that under the staff's initial recommendation, Oregon (and possibly other States, since not all States commented) could have continued its current practice of requiring physicians administering radioactive drugs to humans to be -

specifically licensed, because the generallicense amendments would have been a-Division 2 matter of compatibility.

COORDINATION The Office of the General Counsel has reviev'ed this memorandum and has no legal objection. The Office of the Chief Financial Officer concurs that there will be no resource

~ impacts beyond those currently budgeted. The Office ofi the Chiof b information nd those Officer concurs that there will be no information technology or management mpacts eyo needed for rulemaking.

NOTE:

Unless the Commission directs otherwise within 10 days from the date of this memorandum, I will approve the rulemaking plan and direct the staff to begin development of a direct final rule to permit the distribution of the radioactive drug as an exempt quanti for distribution to and use by any person.

Attachments: 1. Fina! Rulemaking Plan

2. Agreement State Comment Letters cc: OGC, OCA, OIP, CFO, CIO, SECY Distribution:

CTrottier/RPHEB RF, Central File, FCostanzi, LRiani, CGallagher, DMendiola, ATse NMSS: LCamper, DBHowe; OGC: MRothschild, STreby; OSP: LBolling o:\tse\trimed,cet

• See previous conc.

DOCUMENT NAME: at. m w . m m. ... c . c..,..m.a .n= % .ne.ac..u...

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v.. .~. . .,. m.

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11/15/96- l 11/18/96 CIO EDo OSP CFo, OFFICE:. IMNSINMSS ,

GCra Sed HLThompson RSc s DCool RBangart NAME:

1/ 19 7 1/ /97 1/ 19 7  ; il 19 7 DAT E: 1/ 19 7 TUTTI 6AL RECORD COPY RES FILE CCoE No.: 3A-3 s

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1 The Commissioners 4 ,

e Agreement States will r$eed to adopt regulations to allow any person to receive capsules containing 1 Ci of "C-urea as an exemp! quantity.

e The Commission should 'iiote that under the staff's initial recommendation, Oregon an f d. ,

. possibly other States, since not all States commented) could have continued its current-(prac_tice of requiring physicians administering radioactive drugs to humans to be.: ~

specifically licensed, because the generallicense amendments would have been a:

Division 3 matter of com_oatibility.-

1 COOAOINATION ,

rThe Office of the General Counsel has reviewed this memorandum and has no legal 1 objection. The Office of the Chief Financial Officer concurs that thare will be no resource

-Impacts beyond those currently budgeted. The Office of the Chief Information Officer

concurs that there will be no information technology or mana0einent impacts beyond those i needed int rulemaking. .

NOTEt Unless the Commissiond irects otherwise viithin 10 days from the date of this memorandum, I will approve the rulemaking plan and direct the staff to begin development

-of a proposed rule to permit the distribution of the radioactive drug as an exempt quantity .

for distribution to any person.

LAttachmen'ts:

1.- Final Rulemaking Plan

2. Agreement State Comment Letters cc: OGC, OCA, OlP. CFO, ClO. SECY

' Distribution:

t ' CTrottier/RPHEB RFLCentral File, FCostanzi, LRiani,

- CGallagher,' DMendiolai ATse

' NMSSt.LCamper, DBHowe: OGC: MRothschild, STreby: 'OSP: LBolling

• See previous conc.

DOCUMENT NAME: o:\tse\trimed. cat .

ar . ..c.v. . ., .e m,. on,.m. ine... m m. no c . ., mm.wi .n.ewn.nv.netnu... e - e..y -m

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1( 1/ '/97 - 11/- 19 7 1/ 19 7 *[y*/

. 19 7 3 y ] ' DAT E: 19 7 oFfiCIA RECoG CoPT~

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RES FILE CooE _No.: 3A-3

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I ,'

' 2 The Commissioners Unless the Commission directs otherwise within 10 days from the date of)his memorandum, I will approve the rulemaking plan and direct the staff to 6cin development of a direct final rule.

Enclosure:

1. Final Hulemaking Plan

2. Summary of Comments and Responses

3. Agreement State Comment Letters cc: OGC OIP OCA SECY Distribution:

CTrottier/RPHEB RF Central File FCostanti LRiani CGallagher DMendiola ATse LCamper, NMSS DBHowe, NMSS MRothschild, OGC LBolling, OSP STreby. OGC DOCUMENT t'AME: g 1

r,egegves e g yg t Soeg:\ jones nt.ledicatein the t>on\c14f "Ca ermp.ts3 copy without attachnent / enc tosure"A" = copy with DRA/PPHEB D/DRA/REs D/REs i OFFICE: DR RPHEB i BMorr- DMorrison NAME: honesii nbf _ct rot t ie r

/96 11/ /96 11/ /96 fj DATE: 11/ l /96 ' 11/

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OFFICE: EDO ,

NAME: JTaylor l

, D ATE: ill /96 .

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OTFICIAL RECORD COPY RES FILE CODE NO.,3A-3

._